1. Field of the Invention
The present invention relates generally to polypeptide formulations such as those used in the treatment and management of diabetes.
2. Description of Related Art
Advancing technologies have made a wide variety of biologically active polypeptides available in sufficiently large quantities for use in both diagnostic as well as therapeutic methodologies. Many polypeptides, however, can lose biological activity by a variety of chemical and physical means including deamidation, aggregation and denaturation. Consequently, the identification and characterization of compositions and methods that can be used to stabilize and/or assess the stability of these agents is essential for the optimization of their benefits.
Stable polypeptide formulations are particularly important for use in devices that expose these agents to elevated temperatures and/or mechanical stress. Stable glucose oxidase formulations, for example, are used with glucose analyte sensors and related devices in the management of diabetes. Similarly, in continuous infusion systems, a fluid containing a therapeutic agent is pumped from a reservoir, usually to a subcutaneous, intravenous, or intraperitoneal depot. Stable insulin formulations, for example are used with continuous infusion systems and related devices in the treatment of diabetes. Formulations of such polypeptides must remain active even though subjected to extended periods of storage prior to use as well as a patient's body heat and motion during use.